Melbourne biotech ENA Respiratory has raised $34 million (US$22.4m) in a Series B funding round to support the development of its virus-agnostic nasal spray, INNA-051, designed to boost the body’s natural defences against respiratory infections.
The raise was led by existing investors Brandon Capital and Uniseed, with participation from Stoic Venture Capital, the Gates Foundation and a previously announced investment from Flu Lab.
Headquartered in Melbourne with operations in the US, ENA Respiratory was founded in 2020 and is led by CEO Christophe Demaison.
Demaison called the funding a major milestone for ENA Respiratory as it prepares INNA-051 for a community Phase II trial.
INNA-051 is the startup’s lead therapy and is a once-weekly dry powder nasal spray that primes antiviral defenses in the nose — the primary entry point for viruses such as influenza, RSV, rhinovirus, and coronaviruses.
Demaison said ENA Respiratory is tackling a truly global challenge.
“In Australia, around one in four people live with a chronic condition that increases their risk of complications from common respiratory viral infections such as influenza, COVID-19, RSV and the common cold, and hundreds of millions more face the same risks worldwide,” he said.
The company plans to launch its Phase II POSITS community study in the 2025–2026 North American respiratory virus season, recruiting up to 1,100 participants.
The trial will assess the safety, tolerability, and efficacy of up to three months’ treatment with INNA-051, and its effect on the incidence, duration, and severity of respiratory infections among young adults at higher risk due to crowded living or working environments.
“Our goal is to run a globally coherent pivotal program that supports regulatory submissions in Australia, the United States and other key markets. The randomised, placebo-controlled Phase II study is currently being initiated in North America for the 2025/26 respiratory season, with topline data expected in the third quarter of 2026,” said Demaison.
Dr Justin Ortiz, professor of medicine at the University of Maryland’s Center for Vaccine Development and Global Health, will serve as principal investigator.
In parallel, the company is also preparing for the standard end-of-Phase-II interactions with regulatory agencies to “enable early engagement on Phase III planning and registration requirements”.
“If our Phase II data confirm earlier results showing faster viral clearance, INNA-051 could meaningfully reduce illness, healthcare visits and hospitalisations experienced by patients, carers, and the health system,” said Demaison.
“With an international investor syndicate and ongoing support from our Australian investors, we are now in a strong position to evaluate the impact of our once-weekly powder nasal spray in a community setting and move closer to bringing it to the patients who need it most,” he added.
According to the company, it is also partnered with the US’ COPD (chronic obstructive pulmonary disease) Foundation and is the recipient of several contracts from the US government.
ENA director Chris Smith, a partner at Brandon Capital, said the investor recognised the early potential of the nasal spray and its ability to transform the prevention and management of respiratory infections.
“With this new round of funding and the upcoming Phase 2 trial in the United States, ENA Respiratory is well on its way to delivering a therapy that could protect millions of vulnerable people worldwide,” Smith added in a statement.
Smith said the involvement of the Gates Foundation and Flu Jab in the latest round is a “strong endorsement of ENA Respiratory and the INNA-051 program, and their deep expertise and networks in respiratory health, policy and manufacturing will be invaluable as ENA progresses towards late-stage development and scale-up”.
- This story first appeared on SmartCompany. You can read the original here.
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